[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100176572":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":33,"centralContacts":30,"locations":37,"responsibleParty":104,"collaborators":30,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":30,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":30,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":30,"overallStatus":125,"whyStopped":30,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","1 single administration (volume matched to the dose lixisenatide: 50 µL or 100µL) once a day subcutaneously",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Dose 1","EXPERIMENTAL","1 single administration of 5 µg lixisenatide (50 µL) once a day subcutaneously",[19],"Drug: Lixisenatide (AVE0010)",{"label":21,"type":16,"description":22,"interventionNames":23},"Dose 2","1 single administration of 10 µg lixisenatide (100 µL) once a day subcutaneously",[19],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Lixisenatide (AVE0010)","Pharmaceutical form:Solution for injection\n\nRoute of administration: subcutaneous",[15,21],null,{"type":26,"name":9,"description":28,"armGroupLabels":32,"otherNames":30},[9],[34],{"name":35,"affiliation":5,"role":36},"Clinical Sciences & Operations","STUDY_DIRECTOR",[38,51,61,71,82,93],{"facility":39,"status":30,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":30},"Investigational Site Number 840005","Chula Vista","California","91911","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-117.0842,32.64005,{"lat":49,"lon":48},{"facility":52,"status":30,"city":53,"state":54,"zip":55,"country":43,"countryCode":44,"cosmosGeoPoint":56,"geoPoint":60,"contacts":30},"Investigational Site Number 840001","Overland Park","Kansas","66212",{"type":46,"coordinates":57},[58,59],-94.67079,38.98223,{"lat":59,"lon":58},{"facility":62,"status":30,"city":63,"state":64,"zip":65,"country":43,"countryCode":44,"cosmosGeoPoint":66,"geoPoint":70,"contacts":30},"Investigational Site Number 840003","Louisville","Kentucky","40202",{"type":46,"coordinates":67},[68,69],-85.75941,38.25424,{"lat":69,"lon":68},{"facility":72,"status":30,"city":73,"state":30,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":30},"Investigational Site Number 484001","Puebla City","72190","Mexico","MX",{"type":46,"coordinates":78},[79,80],-98.20723,19.04778,{"lat":80,"lon":79},{"facility":83,"status":30,"city":84,"state":30,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":30},"Investigational Site Number 710002","Cape Town","7530","South Africa","ZA",{"type":46,"coordinates":89},[90,91],18.42322,-33.92584,{"lat":91,"lon":90},{"facility":94,"status":30,"city":95,"state":30,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":103,"contacts":30},"Investigational Site Number 826001","Leeds","LS2 9LH","United Kingdom","UK",{"type":46,"coordinates":100},[101,102],-1.54785,53.79648,{"lat":102,"lon":101},{"type":105,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100176572","phase-1-evaluation-of-the-blood-levels-of-the-drug-lixisenatide-the-plasma-glucose-levels-and-safety-in-paediatric-and-adult-patients-with-type-2-diabetes-100176572",false,"NCT01572649","Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes","A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Paediatric (10 - 17 Years Old) and Adult Patients With Type 2 Diabetes","Inclusion criteria :\n\n* Male or female patients with type 2 diabetes mellitus, as defined by WHO (fasting plasma glucose ≥ 7 mmol\u002FL (126mg\u002FdL) or 2 hours postprandial plasma glucose ≥ 11.1 mmol\u002FL (200 mg\u002FdL)), diagnosed for at least 1 year (adults) and at least 3 months for paediatric population at the time of screening visit, with or without metformin (stable dose ± 10 % for at least 4 weeks prior to randomization)\n* HbA1c ≥ 7% and ≤ 10% at screening\n* Age eligibility for paediatric population: ≥ 10 years and \\\u003C18 years with at least 3 patients below 15 years and no more than 3 patients aged between 16 and 18 years; Age eligibility for adults: ≥ 18 and ≤ 65 years\n* For paediatric population:body weight \\>50kg, BMI \\>85th percentile for age and gender and BMI ≤ 50 kg\u002Fm²\n* For adults: BMI \\> 25 kg\u002Fm2 and ≤ 37 kg\u002Fm2\n\nExclusion criteria:\n\n* If female, pregnancy (defined as positive serum pregnancy test), breast-feeding\n* Diabetes other than type 2 diabetes\n* Positive test for insulinoma associated protein (IA2) and glutamic acid decarboxylase (GAD) autoantibodies\n* Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., alpha glucosidase inhibitor, exenatide, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening\n* Allergic reaction to any GLP-1 agonist in the past (e.g. exenatide, liraglutide) or to metacresol\n* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach\u002Fgastric surgery, inflammatory bowel disease\n* Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes)\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","10 Years","65 Years",{"count":117,"type":118},24,"ACTUAL","INTERVENTIONAL",[121],"PHASE1","Primary Objective:\n\n\\- To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls\n\nSecondary Objectives:\n\n\\- To evaluate in both paediatric and adult populations:\n\n* the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses\n* the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast\n* safety and tolerability.",[124],"Type 2 Diabetes Mellitus","COMPLETED","2014-05-22",{"date":128,"type":129},"2014-05-23","ESTIMATED",{"date":131,"type":30},"2012-05",{"date":133,"type":118},"2014-03",{"name":5,"class":6},6]